Risk Factors And Outcomes Of Hospital Acquired AKI

March 15, 2024 updated by: Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD, Alexandria University

Risk Factors And Outcomes Of Hospital Acquired Acute Kidney Injury: A Tertiary Health Care Center Experience

The aim of the study is to assess the common risk factors for development of hospital acquired acute kidney injury among hospitalized patients in Alexandria Main University hospital and their outcomes.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Hospital-acquired AKI (HAAKI) is defined as acute renal insult occurring 48 hours or more after admission to a health care facility and It is estimated to occur in 13-18% of hospitalized patients. The early diagnosis of HAAKI reflects on improvement in morbidity and mortality rates especially in developing countries which goes parallel with the goal The International Society of Nephrology (ISN) to eliminate preventable or treatable deaths from AKI by 2025, the "0 by 25" initiative.

Data concerning the spectrum of acute kidney injury (AKI) in Egypt are generally scarce.

Study Type

Observational

Enrollment (Estimated)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

This research is a prospective cohort study that will include hospitalized patients in Alexandria Main University Hospital (in non-intensive care unit sittings) admitted over a period of sixteen weeks.

Patients will be divided into two groups:

Group (A) : patients who are hospitalized and develop acute kidney injury after 48 hours from admission.

Group (B) : patients who are hospitalized and do not develop acute kidney injury after 48 hours from admission till discharge.

All participants will be followed till discharge and after 3 months to assess outcomes.

Description

Inclusion Criteria:

  1. Fulfilment of definition of acute kidney injury according to KDIGO reference.
  2. Age more than 18 years.

Exclusion Criteria:

  1. Mentally or physically unfit patients.
  2. Patients who developed acute kidney injury within 48 hours of admission to hospital.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AKI group
patients who are hospitalized and develop acute kidney injury after 48 hours from admission
Other: standard AKI care bundle
AKI care bundle include use of iv fluids, diuretics, antihyperkalemic drugs, sodium bicarbonate, antibiotics in septic patients.
no AKI group
patients who are hospitalized and do not develop acute kidney injury after 48 hours from admission till discharge
Other: standard care for hospitalized patients
this includes iv fluids, diuretics, antibiotics in septic patients, other measures according to original disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recovery of kidney functions
Time Frame: 12 weeks
(improvement of eGFR, serum creatinine to normal or previous baseline).
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression to chronic kidney disease.
Time Frame: 12 weeks
deterioration of kidney functions ( creatinine, eGFR)
12 weeks
mortality
Time Frame: 12 weeks
death
12 weeks
Need for renal replacement therapy
Time Frame: 12 weeks
different modalities of RRT
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Investigators

  • Study Chair: Mohamed mamdouh Elsayed, MD, lecturer
  • Principal Investigator: Hala S ElWakil, MD, professor
  • Study Chair: yasmine s naga, MD, ASS. prof
  • Study Chair: sara R Nagib, MBBCh, Resident

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

May 15, 2024

Study Registration Dates

First Submitted

September 17, 2023

First Submitted That Met QC Criteria

September 21, 2023

First Posted (Actual)

September 25, 2023

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 15, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hospiat Acq. AKI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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